Mahapatra et al Journal of Drug Delivery & Therapeutics. 2020; 10(5):333-344 ISSN: 2250-1177 [333] CODEN (USA): JDDTAO Available online on 15.09.2020 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open Access to Pharmaceutical and Medical Research © 2011-18, publisher and licensee JDDT, This is an Open Access article which permits unrestricted non-commercial use, provided the original work is properly cited Open Access Review Article Concept of process capability indices as a tool for process performance measures and its pharmaceutical application Abikesh Prasada Kumar Mahapatra* 1 , Jianwu Song 1 , Zhibo Shao 2 , Tang Dong 2 , Zihong Gong 2 , Basudev Paul 3 , Indira Padhy 4 1,2 Shandong Maichuang Biopharmaceutical Co. Ltd., No. 1 Lutai Ave, Zibo City, Shangdong, CHINA 3 Shanghai Jingfeng Pharmaceutical Co. Ltd., Baoshan, Shanghai, CHINA 4 Khallikote Autonomous College, Berhampur, Ganjam, Odisha-760001, INDIA ABSTRACT The main objective of the present study is to present the concept of process capability and to focus its significance in phar maceutical industries. From a practical view point, the control charts (such as X and R hart) sometimes are not convenient summary statistics when hundreds of characteristics in a plant or supply base are considered. In many situations, capability indices can be used to relate the process parameters. The resulting indices are unit less and provide a common, easily understood language for quantifying the performance of a process. Process capability indices (PCIs) are powerful means of studying the process ability for manufacturing a product that meets specifications. Several capability indices including Cp, Cpu, Cpl and Cpk have been widely used in manufacturing industry to provide common quantitative measures on process potential and performance. The formulas for these indices are easily understood and can be directly implemented. A process capability analysis compares the distribution of output from an in-control process to its specifications limits to determine the consistency with which the specifications can be met. The process capability is also having a significant role in pharmaceutical industry. Process capability indices can be a powerful tool by which to ensure drug product quality and process robustness. Determining process capability provides far more insight into any pharmaceutical process performance than simply computing the percentage of batches that pass or fail each year. Keywords: Process capability; Cp/Cpk; Pp/Ppk; Pharmaceutical quality, process robustness, specification Article Info: Received 08 July 2020; Review Completed 19 August 2020; Accepted 26 August 2020; Available online 15 Sep 2020 Cite this article as: Mahapatra APK, Song J, Shao Z, Dong T, Gong Z, Paul B, Padhy I, Concept of process capability indices as a tool for process performance measures and its pharmaceutical application, Journal of Drug Delivery and Therapeutics. 2020; 10(5):333- 344 http://dx.doi.org/10.22270/jddt.v10i5.4288 *Address for Correspondence: Abikesh Prasada Kumar Mahapatra, Shandong Maichuang Biopharmaceutical Co. Ltd., No. 1 Lutai Ave, Zibo City, Shangdong, CHINA Authors’ contributions We declare that this work was done by the authors named in this article. APKM and JS conceived and designed the study. ZS, TD and ZG collected the information related to article. BP and IP drafted the manuscript. APKM supervised the work and assisted in the final drafting. JS contributed to final revision of the manuscript .All authors have read and approved the final manuscript. Introduction: Over the last 70 years, riding the “continuous quality improvement” wave set in motion by Walter Shewhart and W. Edwards Deming in the 1920s; many different industries have worked hard to better understand their processes in order to improve them. 1 High quality production provides some advantages such as reduced scrap and increased market share. For this purpose there are some requirements to be met. First of all the organization should be cooperative and the quality should come first. On the other hand, in order to meet quality requirements of final product, quality should be achieved at every stage of production. 2 Another way of achieving good quality during production is to use the statistical period techniques at every stage of production. If the production is statistically under control the process can continue and there is no need for a change in the process. However, if it is not statistically under control, the assignable causes should be discovered and removed from the process. Statistical quality control methods apply statistical principles and techniques at every stage of design, manufacturing, and servicing. Statistical quality control methods are quite different from traditional methods and they have made great contribution to improvements in companies dealing with mass production. 3 Statistical methods – statistical process control (SPC), statistical acceptance plans, reliability analysis, statistics in improvement of processes (ANOVA, DOE) etc. belong to basic quality instruments. Statistical analysis can be performed in relation to measurable parameters or, on the